MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number M0066802050

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583); Detachment of Device or Device Component (2907)

Patient Problems Device Embedded In Tissue or Plaque (3165); Unspecified Kidney or Urinary Problem (4503)

Event Date 11/29/2023

Event Type  Injury  

Event Description

Patient was met in the pre-op area (history and physical) and consent reviewed and questions were answered he is in transfer back to the operating room he was placed in supine position general anesthesia was administered by the anesthesia department.He was then placed in the dorso lithotomy position and prepped and draped in the normal sterile fashion a well-lubricated 20 french sheath with 30 degree scope was inserted to the urethra passed into the bladder lumen.The bladder was evaluated entirety and there was no tumors seen.At this point i noted that the ureteral orifice was extremely small.I did attempt to get the pollick past but i was unsuccessful therefore i did have to pass a 3.035 glide wire through the ureteral orifice into the renal pelvis.This barely fit the wire.At this point i was able to just maneuver the pollick into the ureter over the wire but it was difficult.A retrograde pyelogram was performed showing some mid hydronephrosis and a filling defect in the kidney where the stone was.At this point i placed a second wire and attempted to pass a ureteral access sheath over the wire into the ureter however it would not go, it was again just to tight.Therefore i did remove the sheath and decided to place a stent for natural dilation and to come back once the ureter was open.Once i replaced the cystoscope was unable to pass a 6 x 26cm double-j stent over the wire.It would not go past the ureteral orifice.I tried to pass the pollick but again it would not go.I asked for a 4.8 cm stent however they did not have this at the hospital.I then attempted to pass a second wire again and passed the pollick over the second wire but it would not enter the ureteral orifice.I then again attempted to place the stents with a second wire in place but it just would not budge.I then took the needle ureteroscope and after some difficult was able to get it up over a wire into the mid to proximal ureter.I was at the limit of the scope.I could see that part of the clack hydrophilic black coating was missing.This was an extremely small piece.I was able to see this small piece in the proximal ureter however it did go up into the kidney and because i was at the limit of the scope was unable to go more proximal.Due to the extreme narrowing of the distal ureter i knew i was not going to be able to get a flexible ureteroscope up.Therefore i removed the needle scope after i replaced a new wire.The cystoscope was replaced and i was finally able to get a 6 x 26 cm double-j stent over the wire up into the renal pelvis.There was a nice curl distally.The bladder was emptied and reevaluated there is no active bleeding noted.The scope was removed uro-jet was placed.He tolerated the procedure well and is transferred the (post-anesthsia care unit) in stable condition.We will allow the ureter to dilate over the next 3 to 4 weeks and then bring him back for ureteroscopy to remove the stone as well as to remove the small piece of wire coating.

• Brand Name: GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18266938
• MDR Text Key: 329932355
• Report Number: MW5148752
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0066802050
• Device Lot Number: 00816349011757
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Hispanic
• Patient Race: White